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supporting treatment. Therefore, the ROSETTA
(
R
and
O
mized
S
tudy
E
xploring the combination of
radio
T
herapy with
T
wo types of
A
cupuncture treatment)
trial was initiated as a prospective randomized phase II
trial. It examines if traditional (verum-) acupuncture can
reduce RT-related side effects significantly in comparison
to sham (false-) acupuncture.
Material and Methods
A total of 74 patients are to be recruited. In the
experimental arm (n=37) an experienced acupuncture-
trained person will treat dedicated acupuncture points. In
the control arm (n=37) sham-acupuncture will be
performed to provide a blinded comparison of results. The
Ethics Committee of the Technical University of Munich
(TUM) approved the nature and content of the study with
the project number 512/15.
To evaluate quality of life, patients receive a standardized
questionnaire (EORTC QLQ C-30) before their first, after
their fourth and after their last acupuncture treatment.
Further, a study investigator questions patients about
their feelings and symptoms as well as documents detailed
information regarding their course of disease. The main
endpoint of the trial is the improvement of QoL and
reduction of fatigue. Secondary endpoints are the
reduction of RT-related side effects such as headache,
nausea, and pain.
Results
The ROSETTA trial is currently recruiting. Initial results
from 30 patients (verum acupuncture n=15; sham
acupuncture n=15) are presented. All the following items
are scaled from 0 to 100. A high score in a symptom scale
represents an aggravation of symptoms, whereas a high
score in QoL shows an improvement.
Concerning nausea/vomiting and QoL no significant
difference can be observed between the sham-
acupuncture and the verum group. Thus, patients suffer
from a constant level of these side effects during RT. From
the first examination to the last visit, fatigue increases in
the group receiving sham acupuncture (from 21 to 44).
Meanwhile, fatigue remains constant in the verum group
(from 40 to 40). Verum-acupuncture shows positive effects
in reduction of pain (first visit: 21, last visit: 25) in
comparison to the sham-acupuncture group (first visit: 23,
last visit: 30).
Conclusion
We present first results of the ROSETTA trial, which show
preliminary tendencies in 30 randomized patients.
Comparing the verum and the sham-acupuncture group,
some differences regarding fatigue and pain are apparent.
In spite of undergoing RT, patients in both groups do not
feel worse concerning the examined features. Our results
and ongoing research will generate an excellent data basis
on how to include certain complementary medicine
methods into high-end oncology treatment.
EP-1419 Optimal design and patient selection for
interventional trials using radiogenomic biomarkers
D. De Ruysscher
1
, G. Defraene
2
, B. Ramaekers
3
, P.
Lambin
4
, E. Briers
5
, H. Stobart
6
, T. Ward
7
, S. Bentzen
8
, T.
Van Staa
9
, S. Kerns
10
, C. West
11
1
MAASTRO Clinic, Radiation Oncology, Maastricht, The
Netherlands
2
KU Leuven, Radiation Oncology, Leuven, Belgium
3
Maastricht University Medical Center, Department of
Clinical Epidemiology and Medical Technology
Assessment, Maastricht, The Netherlands
4
Maastricht University Medical Center, GROW School for
Oncology and developmental Biology- Department of
Radiation Oncology MAASTRO Clinic, Maastricht, The
Netherlands
5
Patient Advocate, Patient Advocate, Hasselt, Belgium
6
Patient Advocate, Patient Advocate, Cambridge, United
Kingdom
7
Patient Advocate, Patient Advocate, Manchester, United
Kingdom
8
University of Maryland, School of Medicine, Baltimore,
USA
9
University of Manchester, Manchester Academic Health
Science Centre- The Christie NHS Foundation Trust,
Manchester, United Kingdom
10
University of Rochester, Medical Center, Rochester,
USA
11
University of Manchester, Translational Radiobiology
Group I Institute of Cancer Sciences- The Christie NHS
Foundation Trust, Manchester, United Kingdom
Purpose or Objective
To define the optimal design and patient selection for
interventional trials in radiogenomics, as radiogenomics
do not give binary information like in e.g. targetable
mutation biomarkers. Here, the risk to develop severe side
effects is continuous, with increasing incidences of side
effects with higher doses and/or volumes.
Material and Methods
The most appropriate interventions, endpoints, trial
designs, model performance, identification of patient
groups that could benefit most from a radio-genomic
biomarker, and patient considerations were identified.
Patients’ advocacy representatives were part of this work.
Results
Interventions that can be considered are: alternative
treatment, dose modification, altered radiotherapy,
mitigation / amelioration and the omission of
postoperative radiotherapy in patients with a low risk for
tumour recurrence. The optimal intervention is dependent
on pre-defined risk factors, which were identified. There
is clearly no simple endpoint or time point that can be
selected when designing a clinical trial. Composite
endpoints should be considered.
Randomised clinical trials and retrospective observational
studies have pros and cons in radiogenomics, which will be
discussed. As model precision improves, thresholds can be
relaxed, e.g., a very precise model could select patients
for receiving a higher radiation dose with no risk of undue
toxicity. Although more precise models will typically
result in more benefit, less precise models might be
informative to some degree.
The consequences of the incidence of toxicity/toxicities
on the number of patients needed for prospective
validation as a function of the prevalence of a genetic
profile must be considered. A polygenic risk score will
likely be needed as individual genetic variants each
contribute only modestly to risk of developing toxicity.
Decreasing the standard radiation dose in the most
susceptible patients is highly dependent on the dose-
effect relationship.. These relations are highly dependent
on the endpoint, e.g. radiation pneumonitis vs. fibrosis.
An in-depth knowledge of the dose-volume relation for a
specific endpoint taking into account the clinical
usefulness of the dose reduction is needed in order to
select the correct patient for this strategy. For the results
of a study to be of value for patients, there should be a
therapeutic alternative for the standard of care
radiotherapy and the quantitative gain should be
measurable and relevant. The incidence of peak reactions
after radiotherapy is not the only parameter that should
be taken into account. It is their severity, reversibility,
the possible salvage treatments and the overall influence
on quality of life that is also crucial to take into account.
Conclusion
The REQUITE and radiogenomics consortium has defined
recommendations for the optimal design and patient
selection for interventional trials using radiogenomic
biomarkers, which will be presented in detail.
Funding: EU 601826
SK: K07CA187546 NCI USA
EP-1420 Effects of Japanese traditional Kampo
medicines “Goreisan” for acute radiation enteritis